Allergan ($AGN) has filed a de novo application with the FDA for the dry eye device it picked up last year with the $125 million acquisition of Oculeve.
The application is for the Oculeve Intranasal Tear Neurostimulator device, a handheld stimulator that has been studied for temporarily increasing tear production in patients with dry eye disease due to decreased tear production.
The regulatory agency’s de novo classification is an alternate route for devicemakers that classifies novel devices that pose a low to moderate risk to users.
Allergan recently said that two pivotal trials of the device met their effectiveness endpoints.
"The Oculeve Intranasal Tear Neurostimulator is an exciting potential option for patients suffering from dry eye disease, and we are pleased to have filed the de novo application with FDA that will allow patients to gain access to this novel medical device," David Nicholson, Allergan’s head of R&D, said in a statement.
About 31 million people suffer from dry eye disease, the company said. The condition has a number of base causes, including advanced age, contact lens wear, certain medications, eye diseases, and other medical conditions or environmental factors. In the absence of tears, the film protecting the eye can break down, creating dry spots on the cornea.
The company, which has made dry eye products a priority, snapped up Oculeve and its lead program OD-01 last July.
The device is a noninvasive nasal neurostimulation that stimulates tear production and includes an element that is inserted into the mucous membrane of the nasal cavity and another inserted under the skin below the eyebrow. The patient can then manually adjust the rate of tear delivery using a wireless controller.
- here’s the release
Allergan to buy dry eye device startup Oculeve for $125M+